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An Extension Study to Assess Long-Term Safety and Efficacy of Afimkibart in Participants With Rheumatoid Arthritis

NCT07620392

RecruitingPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Rheumatoid Arthritis

Interventions: Afimkibart

Countries: United States, Poland

The study will evaluate the long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with moderate to severe Rheumatoid Arthritis (RA) who have an inadequate response or intolerance to tumor necrosis factor (TNF) and/or Janus kinase (JAK) inhibitors, and who were previously treated with Afimkibart.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Completed the treatment period of the parent study
* Agreement to adhere to the contraception requirements
* Continued to be evaluated at the follow-up visit of the parent study and achieved improvement in the SJC66/TJC68 relative to baseline

Exclusion Criteria:

* Withdrawal of consent and/or premature discontinuation from parent study
* Any permanent discontinuation of study drug in parent study
* Use of a prohibited therapy during the parent study
* Evidence of any new or uncontrolled concomitant disease that, in the investigator's judgment, would preclude participant participation in the trial

Locations (6)

Tamarac, Florida, United States
Houston, Texas, United States
Tomball, Texas, United States
Elblag, Poland
Lublin, Poland
Wroclaw, Poland